Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma

Overview

The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.

SparkCures ID 1131
Trial Phase Phase 2
Enrollment 28 Patients
Treatments
Tags
Trial Sponsors
  • University of Rochester Medical Center Wilmot Cancer Center
NCT Identifier

NCT04635189

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Diagnosis of multiple myeloma with diagnosis
  • Must not have received previous therapy for multiple myeloma
  • Newly diagnosed and not considered candidate for high-dose chemotherapy
  • Adequate organ system function
  • A performance status ≤ 3
  • Ability to swallow and retain oral medication
  • Female subjects of child bearing potential must be surgically sterile, be post-menopausal

Exclusion Criteria:

  • A diagnosis of primary amyloidosis; monoclonal gammopathy of undetermined significance, smoldering multiple myeloma; non-secretory myeloma
  • A diagnosis of Waldenström's disease
  • Receiving cancer therapy
  • Radiation therapy within 14 days of enrollment
  • Major surgery within 2 weeks before enrollment
  • Human immunodeficiency virus -infected patients must be on effective anti-retroviral therapy with undetectable viral load within the past 6 months
  • Seropositive for hepatitis B, or seropositive for hepatitis C
  • Ongoing systemic bacterial, fungal or viral infection
  • Severe and/or uncontrolled medical conditions
  • Malignancy within 2 years of study enrollment
  • Women who are pregnant or lactating
  • Contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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